COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy (IMAGG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03370926
Recruitment Status : Unknown
Verified November 2017 by University Hospital, Brest.
Recruitment status was:  Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema.

To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.

Condition or disease
Glioblastoma Multiforme Anaplastic Astrocytoma Radiotherapy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: (18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Primary Outcome Measures :
  1. Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images [ Time Frame: 12 months ]
    Increase in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique.

Secondary Outcome Measures :
  1. Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET. [ Time Frame: 12 months ]
    Irradiation target volumes associated with standard MRI

  2. Sites of failures with composite and standard MRI based RT planning [ Time Frame: 12 months ]
    Irradiation target volumes associated with standard MRI based RT planning

  3. Progression-free Survival [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients diagnosed with anaplastic astrocytoma or glioblastoma who are referred for adjuvant radiotherapy.

Inclusion Criteria:

  • 18 Years or older
  • Histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma
  • Patients must have undergone surgery with macroscopic complete resection or incomplete resection with residual disease less than 5 cm on MRI
  • An MRI or a scan 48h after surgery should be available
  • WHO ≤ 2
  • Indication for adjuvant radiotherapy
  • Surgery must have been performed 45 days before the start of radiotherapy.
  • Ability to understand and to give consent

Exclusion Criteria:

  • Age < 18 Years.
  • Prior radiation therapy to the brain
  • Any usual formal indication against MRI (claustrophobia, metallic objects or implanted medical devices in body: pacemaker, clips, prostheses ...)
  • Allergic reaction to FET
  • Pregnant women or nursing mothers
  • Refusal to use effective contraception at study entry and throughout the study if patient is of childbearing age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03370926

Layout table for location contacts
Contact: Ulrick SCHICK

Layout table for location information
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Ulrike SCHICK   
Sponsors and Collaborators
University Hospital, Brest
Layout table for additonal information
Responsible Party: University Hospital, Brest Identifier: NCT03370926    
Other Study ID Numbers: IMAGG
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue